Stryker GDC 360 Coils Recalled for Expiration Date Violations
Stryker Neurovascular is recalling GDC 360 coils and related devices shipped to US customers beyond their expiration dates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves shipping devices beyond their expiration date, which is a regulatory and quality control issue. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Neurovascular is recalling specific units of GDC 360 coils, Target coil, and Gateway PTA Balloon Catheter. The recall was initiated because these medical devices were shipped to US customers after they had passed their expiration dates.
The affected products include the GDC-10 360 SOFT 3mm x 6cm SR (Model M003347306SRO, Lot number 14467382, Exp. May 2014). These devices are intended for the embolization of intracranial aneurysms that are considered very high risk or inoperable by traditional techniques.
The recall covers distribution to the states of Virginia, New Hampshire, Ohio, and Texas. No specific illnesses or injuries are reported in the source text. Healthcare providers and patients should verify the expiration dates of these devices and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be…
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model M003347306SRO
- Lot number: 14467382
- Exp. May 2014.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Stryker Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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